Safety Study of Sorafenib With Androgen Deprivation and Radiotherapy to Treat Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Phase I/II Study of Sorafenib Concurrent With Androgen Deprivation and Radiotherapy in the Treatment of Intermediate- and High-Risk Localized Prostate Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00924807
• Other study ID #: IRB# 004-08
• Secondary ID: SR06-959
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: September 2008
• Est. completion date: December 2013

Study information

• Verified date: November 2018
• Source: Beth Israel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety of a new drug- sorafenib, which is to be administered at the same time as standard treatment, which includes hormonal therapy and external beam radiotherapy.

Description:

Leuprolide acetate (a luteinizing hormone releasing hormone (LHRH) agonist) and Bicalutamide (an anti-androgen) are hormonal agents which are commonly used to reduce testosterone blood level for prostate cancer treatment. Intensity modulated external beam radiotherapy is a standard treatment for localized prostate cancer. Previous studies have shown that combining hormonal therapy and radiation is more effective than radiation alone. Unfortunately, significant percentages (50-75%) of patients still relapse. Sorafenib reduces the growth of cancer cells and has proven effective in the treatment of solid tumors including kidney and liver cancer. This drug is approved by the FDA for treatment kidney and liver cancer. The study investigators believe that adding sorafenib to standard treatment, comprising hormonal therapy and radiation, might be more effective then standard hormonal therapy.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients must have histologically confirmed intermediate or high risk prostate adenocarcinoma. Intermediate risk disease comprises T2b/c tumors, Gleason 7 histology, or PSA 10-20. High risk tumors comprise T3-4, Gleason 8 or higher histology, or PSA greater than 20.

• Age > 18 years.

• Life expectancy of greater than 5 years.

• Patients must have normal organ and marrow function.

• No pelvic lymph node metastases based on pelvic CT scan or MRI.

• No bone metastasis. A whole body bone scan is required to rule out metastatic disease.

Exclusion Criteria:

• Any previous, radiotherapy, or chemotherapy, or more than 4 weeks of androgen deprivation hormonal therapy for the treatment of prostate adenocarcinoma.

• Patients may not be receiving any other investigational agents.

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to sorafenib or other agents used in this study.

• Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.

• Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin will not be allowed to participate.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Leuprolide acetate, Bicalutamide, Sorafenib
Leuprolide acetate - depot, Bicalutamide 50 mg, Sorafenib 400mg

Locations

Country	Name	City	State
United States	St.Luke's-Roosevelt Hospital Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Medical Center	Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the Safety and Maximally Tolerated Dose of Sorafenib Administered Concurrently With Radiotherapy in the Treatment of Intermediate- and High-risk Localized Prostate Cancer.	Data of zero ("0") participants were analyzed due to lack of funding and prematurely terminating the study by sponsor. All subjects are following up in the clinic off the study.	Day 29 and every 2 weeks
Secondary	Biochemical Disease-free Survival	Data of zero ("0") participants were analyzed due to lack of funding and prematurely terminating the study by sponsor. All subjects are following up in the clinic off the study.	after 9 months